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The new blueprint for oncology trials: agility, consistency, and scale
Oncology has never been in a better scientific position. Precision medicines, adaptive study designs, and biomarker-driven cohorts have opened up treatment possibilities that simply did not exist ten years ago. But the complexity of running these trials has grown at much the same pace as the science itself, and that gap between scientific ambition and operational capability is where many programmes quietly struggle.
For sponsors building oncology portfolios, and for the CROs executing them, the operational challenge is no longer a peripheral concern. Getting it right comes down to three things: being consistent enough to build efficiently, agile enough to adapt when the science changes, and scalable enough to manage a growing portfolio without the overhead growing at the same rate.
Medable has worked with sponsors and CROs across many global oncology programmes, spanning thousands of sites and participants. That experience has given us a clear picture of what separates programmes that move well from those that get stuck.
If patients withdraw, critical data Is lost: Rethinking long-term follow-up in C> Trials
This session explores a digital-first approach to long-term follow-up designed to sustain participant engagement, reduce attrition, and maintain scientific and regulatory rigor for cell and gene therapies.
Playing catch-up: FDA wants “patient’s voice” ePRO in your oncology trial
For years now, the FDA has been making one point crystal clear to sponsors and CROs across our industry; they want the patient voice incorporated whenever possible in oncology trials.
The FDA's initiative is driven by the recognition that a patient's personal experience with a disease and its treatment is a unique and essential measure of a medical product's benefit and risk.
- Rationale: The FDA explicitly states that "patients provide a unique perspective on treatment effectiveness" and "some treatment effects are known only to the patient." Outcomes that truly matter to patients, such as functioning, quality of life, and the burden of side effects, are often best measured directly by the patient.
- Mandate: The Patient-Focused Drug Development (PFDD) effort, codified in part by the 21st Century Cures Act, requires the inclusion of such patient experience data in clinical research.
- Guidance series: To formalize this approach, the FDA has released a series of methodological guidance documents (the PFDD Guidance Series) that outline how stakeholders should collect, submit, and use patient input to inform medical product development.